CLASS II Drug recall · Reported 23 May 2018 · FDA Enforcement Report
Clindamycin, USP M-Pak container recalled by Prescript Pharmaceuticals
Prescript Pharmaceuticals is recalling Clindamycin, USP M-Pak container, distributed in California. The recall was initiated on 24 Apr 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0805-2018
- FDA event ID
- 79961
- Recalling firm
- Prescript Pharmaceuticals, Pleasanton, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2018
- FDA classified
- 14 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antibiotics
Timeline
| 24 Apr 2018 | Recall initiated by company | |
| 14 May 2018 | Classified by FDA | +20 days |
| 23 May 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Product as listed by the FDA
Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: Lannett Co. Inc., Philadelphia, PA. Pckgd by PreScript Pharm. Inc. Pleasanton, CA 94566. NC 00527-1382-01, Bar Code 0639-30-176
Where it was distributed
California.
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Which lots are affected?
Lot # 0130126
Where was it sold?
California.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 79961This product is part of a recall event; the main page for the event is Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers recalledAcetaminophen And Codeine Phosphate | Prescript Pharmaceuticals | Other | CA | |
| CLASS II | Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers recalled | Prescript Pharmaceuticals | Foreign Material | CA | |
| CLASS II | Chlorhexidine 0.12% liquid, 473 Milliters recalled | Prescript Pharmaceuticals | Other | CA | |
| CLASS II | Clindamycin, USP M-Pak containers recalled by Prescript Pharmaceuticals | Prescript Pharmaceuticals | Other | CA |
More recalls from Prescript Pharmaceuticals
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin, USP M-Pak containers recalled by Prescript Pharmaceuticals | Prescript Pharmaceuticals | Other | CA |
| Drug | CLASS II | Chlorhexidine 0.12% liquid, 473 Milliters recalled | Prescript Pharmaceuticals | Other | CA |
| Drug | CLASS II | Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers recalled | Prescript Pharmaceuticals | Foreign Material | CA |
| Drug | CLASS II | Acetaminophen 300 mg with Codeine Phosphate, USP M-Pak containers recalledAcetaminophen And Codeine Phosphate | Prescript Pharmaceuticals | Other | CA |
Other Clindamycin recalls
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 600 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |