Multiple Rapid and Recall Alerts ⚠️ for Spurious and Substandard Medications issued by DRAP

1. Rapid Alert – Spurious Terbiderm Forte & Glantrim Ophthalmic Solution

2. Recall Alert – Curosurf (Chiesi Pharmaceuticals) (Class II Recall – WHO)

3. Rapid Alert – Spurious Dydrogesterone Tablets

4. Rapid Alert – Spurious Nandrolone Injection

5. Recall Alert – Substandard Injectable Products (Hicobal Injection, Sidofenac Injection, Neocobal Injection, Sporex Injection, MECOJIN Injection, Metiver Injection, IPROLAC Injection, EPHASEF 1G Injection, Cara-Doba Injection)

6. Recall Alert – Substandard Oral Products (Acefyl Cough Syrup, Ortizin Tablets, Loratamin Tablets, Kadin Tablets, Nitras Tablets)

On 14-April-2026: DRAP Issued 6 Major Rapid & Recall Alerts of spurious and substandard medications

Rapid Alert – Spurious Terbiderm Forte & Glantrim Ophthalmic Solution

DRAP Alert No: I/S/04-26-18
Date: 14 April 2026

Issue Summary

Atco Laboratories Limited, Karachi reported detection of suspected spurious batches of:

Terbiderm Forte Tablet (Terbinafine 250 mg)
Glantrim Ophthalmic Solution

Laboratory testing confirmed absence of active pharmaceutical ingredient (API) (below detection limit). Differences were also found in:

Packaging
Labeling
Physical characteristics

These products are declared Spurious under Section 3(zb) of Drugs Act, 1976.

Affected Products

Terbiderm Forte Tablet (Terbinafine 250 mg)
- Reg # 053367
- Batch: HH003L
- Manufacturer: M/s Atco Laboratories Limited, Karachi (DML # 000188)
- Status: Spurious
Glantrim Ophthalmic Solution
- Timolol (as Maleate) = 0.5%w/v Dorzolamide (As HCl) = 2%w/v
- Reg # 050622
- Batch: LZ010K
- Status: Spurious

Therapeutic Use

Treatment of fungal infections (Terbiderm Tablets)
Management of glaucoma and ocular hypertension (Glantrim Ophthalmic Solution)

Risk

Complete treatment failure
Disease progression
Serious complications (especially vision-related risks)

Recall Alert – Curosurf (Class II Recall – WHO)

DRAP Alert No: II/S/04-26-19
Date: 14 April 2026

Issue Summary

WHO notified DRAP of a Class II recall due to microbial contamination risk in Curosurf (Poractant alfa).
Identified by State Institute for Drug Control (SUKL), Czech Republic.

Affected Products

Curosurf 1.5 ml vial (80 mg/ml)
- (Pulmonary surfactant of Natural origin 80mg / ml – Corresponding to approx 74.0 of total phospholipids) Each vial contains: Poractant Alfa 120mg/1.5ml
- Batches: 1211476, 1224477, 1223964, 1204306
Curosurf 3 ml vial (80 mg/ml)
- (Pulmonary surfactant of Natural origin 80mg / ml – Corresponding to approx 74.0 of total phospholipids) Each vial contains: Poractant Alfa 240mg/3 ml
- Batch: 1226985
Manufacturer:
M/s Chiesi Farmaceutici S.p.A, Italy
Importer:
Chiesi Pharmaceuticals (Pvt) Ltd, Lahore

Therapeutic Use

Treatment of Respiratory Distress Syndrome (RDS) in premature infants

Risk

Severe infections due to contamination
Life-threatening complications in neonates
High risk in NICU patients

Rapid Alert – Spurious Dydrogesterone Tablets

DRAP Alert No: I/S/04-26-20
Date: 14 April 2026

Issue Summary

Drug Testing Laboratory (Punjab) declared multiple Dydrogesterone products spurious:

API not detected (0% assay)
Failed identification and dissolution

Affected Products

Dropha Tablets (Dydrogesterone 10 mg)
- Batch: DRP-0011
- Manufacturer: M/s Himax Pharmaceutical, Karachi
- Issue: API not detected, Assay 0%, fails identification & dissolution
Efaston Tablets 10 mg
- Batch: 4116
- Manufacturer: M/s Lahore Chemical & Pharmaceutical Works (DML# 000064)
- Issue: API not detected, Assay 0%, fails identification & dissolution
Depasrone Tablets 10 mg
- Batch: 2648
- Manufacturer: M/s Alpine Laboratories, Karachi
- Issue: API not detected, Assay 0%, fails identification & dissolution

Therapeutic Use

Gynecological and obstetric conditions
Hormonal therapy

Risk

Therapeutic failure
Pregnancy complications
Risks to maternal health

Rapid Alert – Spurious Nandrolone Injection

DRAP Alert No: I/S/04-26-21
Date: 14 April 2026

Issue Summary

DTL Punjab reported spurious injectable product:

API not detected (0% assay)
Failed identification test

Affected Product

Deka-Duralin Injection 100 mg/ml (Nandrolone Decanoate)
- Reg. No. 074187
- Batch: H-191
- Puroported Manufacturer: Hansel Pharmaceuticals (Pvt.) Ltd., Lahore

Therapeutic Use

Anabolic steroid therapy

Risk

Complete treatment failure
Potential serious health risks

Recall Alert – Substandard Injectable Products (Punjab DTL)

DRAP Alert No: I/S/03-26-22
Date: 14 April 2026

Issue Summary

Multiple injectable drugs declared:

Substandard
Adulterated
Misbranded

Affected Products

Cara-Doba Injection (Dobutamine 250 mg/5ml)
- Reg # 054987
- Batches: 26A037, 25J016
- Manufacturer: Caraway Pharmaceuticals (DML # 000629)
- Issue: Particulates + assay failure
EPHASEF 1G Injection (Cephradine)
- Reg # 044343
- Batch: EM073
- Manufacturer: E-Pharm Laboratories (DML # 000598)
- Issue: Sterility failure
IPROLAC Injection (Ketorolac 30mg/mL)
- Reg # 112065
- Batch: 25L048
- Manufacturer: Ipram International (DML # 000551)
- Issue: Sterility + misbranding (Product label bears, product specs: whereas monograph of exists in USP 2025, which manufacturer failed to provide is “Ketorolac specifications” from registration board. not Innovator’s Tromethamine Specifications prescribed on the approval letter of injection” label, and “Innovator’s)
Metiver Injection (Mecobalamin 500mcg)
- Reg # 098031
- Batch: 25J438
- Manufacturer: Iqra Pharmaceuticals (DML # 000899)
- Issue: Assay failure + adulteration (Cyanocobalamin is Identified).
MECOJIN Injection (Mecobalamin)
- Reg. # 124090
- Batch: 25A082
- Manufacturer: Islam Pharmaceuticals (DML # 000885)
- Issue: Adulteration (Cyanocobalamin is Identified).
Sporex Injection (Ceftriaxone)
- Reg. # 055202
- Batch: 98101
- Manufacturer: Raazee Therapeutics (DML # 000437)
- Issue: Sterility failure
Neocobal Injection (Mecobalamin)
- Reg # 071447
- Batch: S–2988
- Manufacturer: Pulse Pharmaceuticals (DML # 000564)
- Issue: Assay failure + adulteration (Cyanocobalamin is Identified).
Sidofenac Injection (Diclofenac)
- Reg # 086452
- Batch: DI0016
- Manufacturer: N.S Pharma (DML # 000869)
- Issue: Visible particulates
Hicobal Injection (Mecobalamin)
- Reg # 032320
- Batch: HT13437
- Manufacturer: Himont Pharmaceuticals (DML # 000231)
- Issue: Assay failure + adulteration (Cyanocobalamin is Identified).

Therapeutic Use

Cardiac support (Dobutamine)
Antibiotic therapy (EPHASEF 1G & Sporex Injection)
Pain management (Sidofenac & IPROLAC Injections)
Vitamin B12 deficiency treatment (Hicobal, neocobal, mecojin & metiver injection)

Risk

Severe infections
Treatment failure
Toxicity or adverse reactions
Life-threatening complications

Recall Alert – Substandard Oral Products

DRAP Alert No: I/S/03-26-23
Date: 14 April 2026

Issue Summary

Oral medicines declared substandard/adulterated, including contamination issues.

Affected Products

Nitras Tablets (Glycerin Trinitrate 2.6 mg)
- Reg # 056007
- Batch: 24L069
- Manufacturer: Caraway Pharmaceuticals (DML # 000629)
- Issue: Assay & dissolution test failure
Kadin Tablets (Tizanidine 2 mg)
- Reg # 033347
- Batch: 569
- Manufacturer: FYNK Pharmaceuticals (DML # 000494)
- Issue: Adulteration (Paracetamol detected)
Loratamin Tablets (Loratadine 10 mg)
- Reg # 062647
- Batch: 24
- Manufacturer: Murfy Pharmaceuticals (DML # 000543)
- Issue: Adulteration
Acefyl Cough Syrup
- contains: Acefylline Piperazine….45mg, Diphenhydramine HCl…8mg
- Reg # 023394
- Batch: ACH479
- Manufacturer: NABIQASIM Industries (DML # 000105)
- Issue: Glass particle contamination
Ortizin Tablets (Cetirizine 10 mg)
- Reg # 025405
- Batch: 25F135
- Manufacturer: Obsons Pharmaceuticals (DML # 000416)
- Issue: Assay failure + impurities

Therapeutic Use

Cardiac conditions (Nitras Tablets)
Allergy treatment (Ortizin & Loratamin Tablets)
Muscle relaxant therapy (Kadin Tablets)
Cough management (Acefyl Cough Syrup )

Risk

Reduced efficacy
Unexpected side effects
Physical harm (e.g., glass contamination)
Poor disease control

Actions Taken

The Regulatory Field Force has been instructed to conduct surveillance and seize the above-mentioned batch of the medication.

Pharmacists, chemists, distributors, and healthcare professionals must urgently inspect their stocks. Details of suppliers of such products should be reported to the Regulatory Field Force (DRAP and Provincial Drug Control Departments) to ensure removal from circulation.

Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms@dra.gov.pk.

Guidance for Healthcare Professionals

Any adverse events or quality concerns linked to these medicines should be reported to the National or Provincial Pharmacovigilance Centres via the Adverse Event Reporting Form or through the official online portal.

How to download VigiMobile App for ADRs reporting

Guidance for Consumers

Consumers must avoid this product. If anyone experiences health problems after using them, they should immediately consult a healthcare provider and report the incident to DRAP / the National Pharmacovigilance Centre.

Always purchase therapeutic goods only from licensed pharmacies or authorized outlets. Carefully check the authenticity and condition of products, and consult a pharmacist or healthcare professional in case of doubt.

References:

Drug Regulatory Authority of Pakistan. (2026, April 14). Rapid alert – Spurious Terbiderm Forte tablet (Terbinafine 250 mg) & Glantrim ophthalmic solution.

https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/18-rapid-alert-spurious-terbiderm-forte-tablet-terbinafine-250-mg-glantrim-ophthalmic-solution/

Drug Regulatory Authority of Pakistan. (2026, April 14). Recall alert – WHO recall class-II.
https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/19-recall-alert-who-recall-class-ii/

Drug Regulatory Authority of Pakistan. (2026, April 14). Rapid alert – Spurious dydrogesterone tablets.
https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/20-rapid-alert-spurious-dydrogesterone-tablets/

Drug Regulatory Authority of Pakistan. (2026, April 14). Rapid alert – Spurious nandrolone injection 100 mg/ml.
https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/21-rapid-alert-spurious-nandrolone-injection-100mg-ml/

Drug Regulatory Authority of Pakistan. (2026, April 14). Recall alert – Drug products declared substandard by provincial laboratories.
https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/22-recall-alert-drug-products-declared-substandard-by-provincial-laboratories/

Drug Regulatory Authority of Pakistan. (2026, April 14). Recall alert – Class II drug products (provincial reports).
https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/23-recall-alert-class-ii-drug-products-provincial-reports/